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Regulatory Intelligence

FDA & Regulatory
Tracker

Compounding eligibility, WADA classifications, country-by-country regulations, and safety red flags for research peptides.

Eligible

(6)

Sermorelin

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Sermorelin was previously FDA-approved (Geref) but discontinued commercially. Now available through compounding pharmacies with a valid prescription.

Updated: 2025-12-01

Gonadorelin

NAD+ (Nicotinamide Adenine Dinucleotide)

NAD+ is available through compounding pharmacies and as a supplement (NR/NMN precursors).

Glutathione

Available through compounding pharmacies for SC/IV use under 503A

Updated: 2025-06

L-Carnitine (Injectable)

Available through compounding pharmacies; also FDA-approved as Carnitor

Updated: 2025-06

GHK (Glycyl-Histidyl-Lysine)

Available through compounding pharmacies for topical and injectable use

Updated: 2025-06

Under Review

(2)

LL-37

LL-37 compounding eligibility is under FDA review. Status may change based on PCAC recommendations.

Updated: 2025-12-01

Kisspeptin

Removed from Category 2

(2)

BPC-157

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Removed from Category 2 on April 15, 2026 after HHS Secretary Kennedy directed withdrawal. PCAC review scheduled July 23-24, 2026 to determine compounding eligibility.

Updated: 2026-04-15

Thymosin Beta-4

Previously available through compounding pharmacies; FDA removed from bulk drug substance list

Updated: 2025-06

Ineligible

(100)

TB-500

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TB-500 is not on the FDA 503A bulk drug substance list for compounding.

Updated: 2025-12-01

Ipamorelin

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Ipamorelin is not on the FDA 503A bulk drug substance list for compounding.

Updated: 2025-12-01

CJC-1295

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CJC-1295 is not on the FDA 503A bulk drug substance list for compounding.

Updated: 2025-12-01

GHK-Cu

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GHK-Cu (injectable) is not on the FDA 503A bulk drug substance list for compounding. Topical formulations may be available through compounding pharmacies.

Updated: 2025-12-01

Melanotan II

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Melanotan II is not on the FDA 503A bulk drug substance list. Not approved for any human use in any jurisdiction.

Updated: 2025-12-01

AOD-9604

AOD-9604 is not on the FDA 503A bulk drug substance list for compounding. Has FDA GRAS status as a food ingredient only.

Updated: 2025-12-01

MOTS-c

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MOTS-c is not on the FDA 503A bulk drug substance list for compounding.

Updated: 2025-12-01

GHRP-6

GHRP-6 is not on the FDA 503A bulk drug substance list for compounding.

Updated: 2025-12-01

GHRP-2

GHRP-2 (pralmorelin) is not on the FDA 503A bulk drug substance list for compounding. Approved as a diagnostic agent in Japan only.

Updated: 2025-12-01

Epithalon

Thymosin Alpha-1

Selank

Semax

Dihexa

DSIP

MK-677

KPV

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Hexarelin

IGF-1 LR3

FOXO4-DRI

Humanin

PEG-MGF

5-Amino-1MQ

Follistatin 344

Amylin

Endogenous hormone; synthetic analog pramlintide is the approved therapeutic

Updated: 2025-06

Alexamorelin

Research peptide; not eligible for compounding under 503A

Updated: 2025-06

Tabimorelin

Discontinued research compound; not eligible for compounding

Updated: 2025-06

MGF

Research peptide; not eligible for compounding under 503A

Updated: 2025-06

IGF-1 DES

Research peptide; not eligible for compounding under 503A

Updated: 2025-06

HGH Fragment 176-191

Research peptide fragment; not eligible for compounding under 503A

Updated: 2025-06

Larazotide

Investigational drug; not eligible for compounding under 503A

Updated: 2025-06

Thymulin

Research peptide; not an FDA-approved drug

Updated: 2025-06

Beta-Defensins

Endogenous antimicrobial peptides; no therapeutic product

Updated: 2025-06

Alpha-Defensins

Endogenous antimicrobial peptides; no therapeutic product

Updated: 2025-06

Lactoferricin

Naturally derived antimicrobial peptide; no FDA-approved formulation

Updated: 2025-06

Melittin

Bee venom-derived peptide; research use only

Updated: 2025-06

Histatin-5

Endogenous salivary peptide; no therapeutic product

Updated: 2025-06

Pexiganan

Investigational antimicrobial peptide; FDA approval denied

Updated: 2025-06

Omiganan

Investigational antimicrobial peptide; not FDA-approved

Updated: 2025-06

Brilacidin

Investigational defensin-mimetic; not FDA-approved

Updated: 2025-06

IM862

Investigational peptide; development discontinued

Updated: 2025-06

Noopept

Research nootropic; not FDA-approved; sold as supplement in some markets

Updated: 2025-06

Pinealon

Research peptide; not FDA-approved

Updated: 2025-06

Cortagen

Research peptide; not FDA-approved

Updated: 2025-06

N-Acetyl Semax Amidate

Research nootropic; not FDA-approved; derivative of Semax

Updated: 2025-06

PE-22-28

Research peptide; not FDA-approved

Updated: 2025-06

Substance P

Endogenous neuropeptide; not an FDA-approved drug product

Updated: 2025-06

Neuropeptide Y

Endogenous neuropeptide; not an FDA-approved drug product

Updated: 2025-06

VIP (Vasoactive Intestinal Peptide)

Endogenous neuropeptide; aviptadil (synthetic VIP) has received Emergency Use Authorization research but is not fully FDA-approved

Updated: 2025-06

PACAP

Endogenous neuropeptide; not an FDA-approved drug product

Updated: 2025-06

Angiotensin 1-7

Research peptide; not eligible for compounding under 503A

Updated: 2025-06

Bradykinin

Endogenous peptide used in research; not eligible for compounding

Updated: 2025-06

Atrial Natriuretic Peptide

Research peptide; not eligible for compounding under 503A

Updated: 2025-06

B-type Natriuretic Peptide

Endogenous peptide used in diagnostics; not eligible for compounding

Updated: 2025-06

Endothelin-1

Research peptide; not eligible for compounding under 503A

Updated: 2025-06

Apelin

Research peptide; not eligible for compounding under 503A

Updated: 2025-06

Adrenomedullin

Research peptide; not eligible for compounding under 503A

Updated: 2025-06

Somatostatin

Endogenous peptide; synthetic analogs are FDA-approved instead

Updated: 2025-06

HCG

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FDA removed HCG from bulk compounding list; biologics license required

Updated: 2025-06

AICAR

Research compound; not eligible for compounding under 503A

Updated: 2025-06

Adamax

Research peptide; not eligible for compounding under 503A

Updated: 2025-06

Adipotide

Research peptide; not eligible for compounding under 503A

Updated: 2025-06

PNC-27

Research peptide; not eligible for compounding under 503A

Updated: 2025-06

SLU-PP-332

Research compound; not eligible for compounding under 503A

Updated: 2025-06

Neuroxelin

Research peptide; not eligible for compounding under 503A

Updated: 2025-06

Thymalin

Khavinson bioregulator peptide; not eligible for compounding under 503A

Updated: 2025-06

Vilon

Khavinson bioregulator peptide; not eligible for compounding under 503A

Updated: 2025-06

Livagen

Khavinson bioregulator peptide; not eligible for compounding under 503A

Updated: 2025-06

Bronchogen

Khavinson bioregulator peptide; not eligible for compounding under 503A

Updated: 2025-06

Cardiogen

Khavinson bioregulator peptide; not eligible for compounding under 503A

Updated: 2025-06

Pancragen

Khavinson bioregulator peptide; not eligible for compounding under 503A

Updated: 2025-06

Vesilute

Khavinson bioregulator peptide; not eligible for compounding under 503A

Updated: 2025-06

Testagen

Khavinson bioregulator peptide; not eligible for compounding under 503A

Updated: 2025-06

Prostamax

Khavinson bioregulator peptide; not eligible for compounding under 503A

Updated: 2025-06

Chonluten

Khavinson bioregulator peptide; not eligible for compounding under 503A

Updated: 2025-06

ACE-031

Investigational biologic; not eligible for compounding under 503A

Updated: 2025-06

Tat-Beclin 1

Research peptide; not eligible for compounding under 503A

Updated: 2025-06

B7-33

Research peptide; not eligible for compounding under 503A

Updated: 2025-06

Cartalax

Khavinson bioregulator peptide; not eligible for compounding under 503A

Updated: 2025-06

FGL(S)

Research peptide; not eligible for compounding under 503A

Updated: 2025-06

Follistatin-315

Research protein; not eligible for compounding under 503A

Updated: 2025-06

Melanotan I (Afamelanotide)

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Research peptide; afamelanotide (Scenesse) is the FDA-approved analog

Updated: 2025-06

N-Acetyl Epithalon Amidate

Research peptide; not eligible for compounding under 503A

Updated: 2025-06

N-Acetyl Selank Amidate

Research peptide; not eligible for compounding under 503A

Updated: 2025-06

OS-01 (OneSkin Peptide)

Research peptide; not eligible for compounding under 503A

Updated: 2025-06

Ovagen

Khavinson bioregulator peptide; not eligible for compounding under 503A

Updated: 2025-06

TB-500 Fragment 17-23

Research peptide fragment; not eligible for compounding under 503A

Updated: 2025-06

Thymagen

Khavinson bioregulator peptide; not eligible for compounding under 503A

Updated: 2025-06

Vesugen

Khavinson bioregulator peptide; not eligible for compounding under 503A

Updated: 2025-06

Tesofensine

Small molecule drug, not a peptide. Not eligible for 503A compounding.

PTD-DBM

Not listed on FDA bulk drug substance list for compounding.

GDF-11

Not listed on FDA bulk drug substance list. Research reagent only.

P21

Not listed on FDA bulk drug substance list.

Neuromedin U

Not listed on FDA bulk drug substance list.

Uroguanylin

Not listed on FDA bulk drug substance list. Related approved drugs (linaclotide) exist.

Thymogen

Not listed on FDA bulk drug substance list. No Western regulatory recognition.

Cerluten

Not recognized by FDA. Animal tissue-derived product.

Kristagen

Not recognized by FDA. Animal tissue-derived product.

Astressin-B

Not listed on FDA bulk drug substance list.

Zhenoluten

Not recognized by FDA. Animal tissue-derived product.

Not Applicable

(124)

Semaglutide

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Semaglutide is an FDA-approved drug (Ozempic, Wegovy, Rybelsus). Compounding is subject to FDA enforcement and ongoing litigation.

Updated: 2025-12-01

Tirzepatide

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Tirzepatide is an FDA-approved drug (Mounjaro, Zepbound). Compounding subject to FDA enforcement.

Updated: 2025-12-01

PT-141

Bremelanotide (PT-141) is an FDA-approved drug marketed as Vyleesi for hypoactive sexual desire disorder in premenopausal women.

Updated: 2025-12-01

Tesamorelin

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Tesamorelin is an FDA-approved drug marketed as Egrifta/Egrifta SV for HIV-associated lipodystrophy.

Updated: 2025-12-01

Retatrutide

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Retatrutide is in clinical trials by Eli Lilly; not available for compounding.

SS-31

SS-31 (elamipretide) is in clinical trials; not available for compounding.

Cerebrolysin

Cerebrolysin is approved in some countries as a pharmaceutical product; not compoundable in the US.

Liraglutide

Liraglutide is FDA-approved as Victoza (diabetes) and Saxenda (obesity).

Cagrilintide

Cagrilintide is in clinical trials by Novo Nordisk.

Survodutide

Survodutide is in clinical trials by Boehringer Ingelheim.

Argireline

Argireline is a cosmetic ingredient, not a drug subject to 503A compounding rules.

ARA-290 (Cibinetide)

ARA-290 (cibinetide) is in clinical trials with FDA Orphan Drug Designation.

Exenatide

FDA-approved branded product (Byetta/Bydureon)

Updated: 2025-06

Dulaglutide

FDA-approved branded product (Trulicity)

Updated: 2025-06

Lixisenatide

FDA-approved branded product (Adlyxin)

Updated: 2025-06

Albiglutide

FDA-approved (Tanzeum); discontinued from market 2018

Updated: 2025-06

Pramlintide

FDA-approved branded product (Symlin)

Updated: 2025-06

Calcitonin (Salmon)

FDA-approved (Miacalcin/Fortical for osteoporosis)

Updated: 2025-06

Setmelanotide

FDA-approved branded product (Imcivree) for rare genetic obesity

Updated: 2025-06

Mazdutide

Investigational dual GLP-1/glucagon receptor agonist; not yet approved

Updated: 2025-06

Pemvidutide

Investigational dual GLP-1/glucagon receptor agonist; not yet approved

Updated: 2025-06

Cotadutide

Investigational dual GLP-1/glucagon receptor agonist; not yet approved

Updated: 2025-06

Danuglipron

Investigational oral GLP-1 receptor agonist (small molecule); not yet approved

Updated: 2025-06

Orforglipron

Investigational oral GLP-1 receptor agonist (small molecule); not yet approved

Updated: 2025-06

Oxytocin

FDA-approved branded product (Pitocin)

Updated: 2025-06

Vasopressin

FDA-approved (Vasostrict) for vasodilatory shock

Updated: 2025-06

Desmopressin

FDA-approved (DDAVP/Stimate) for diabetes insipidus, hemophilia A, nocturnal enuresis

Updated: 2025-06

Terlipressin

FDA-approved (Terlivaz) for hepatorenal syndrome

Updated: 2025-06

Carbetocin

Approved in many countries for PPH prevention; not FDA-approved in US

Updated: 2025-06

Leuprolide

FDA-approved (Lupron, Eligard) for prostate cancer, endometriosis, CPP

Updated: 2025-06

Goserelin

FDA-approved (Zoladex) for prostate cancer, breast cancer, endometriosis

Updated: 2025-06

Triptorelin

FDA-approved (Trelstar) for advanced prostate cancer

Updated: 2025-06

Nafarelin

FDA-approved (Synarel) for endometriosis and CPP

Updated: 2025-06

Histrelin

FDA-approved (Vantas, Supprelin LA) for prostate cancer and CPP

Updated: 2025-06

Degarelix

FDA-approved (Firmagon) for advanced prostate cancer

Updated: 2025-06

Ganirelix

FDA-approved (Ganirelix Acetate Injection) for controlled ovarian stimulation

Updated: 2025-06

Cetrorelix

FDA-approved (Cetrotide) for controlled ovarian stimulation

Updated: 2025-06

Buserelin

Approved in Europe and Canada (Suprefact); not FDA-approved in US

Updated: 2025-06

Macimorelin

FDA-approved diagnostic agent (Macrilen)

Updated: 2025-06

Growth Hormone

FDA-approved biologic (multiple brands); not a compounded product

Updated: 2025-06

IGF-1

FDA-approved biologic (Increlex); not a compounded product

Updated: 2025-06

Collagen Peptides

Dietary supplement; not regulated as a drug

Updated: 2025-06

Matrixyl

Cosmetic ingredient; not regulated as a drug

Updated: 2025-06

Matrixyl 3000

Cosmetic ingredient; not regulated as a drug

Updated: 2025-06

Snap-8

Cosmetic ingredient; not regulated as a drug

Updated: 2025-06

Palmitoyl Tripeptide-1

Cosmetic ingredient; not regulated as a drug

Updated: 2025-06

Palmitoyl Tetrapeptide-7

Cosmetic ingredient; not regulated as a drug

Updated: 2025-06

Palmitoyl Tripeptide-5

Cosmetic ingredient; not regulated as a drug

Updated: 2025-06

Copper Tripeptide-1

Cosmetic ingredient; not regulated as a drug

Updated: 2025-06

Acetyl Tetrapeptide-5

Cosmetic ingredient; not regulated as a drug

Updated: 2025-06

Tripeptide-29

Cosmetic ingredient; not regulated as a drug

Updated: 2025-06

Myristoyl Pentapeptide-17

Cosmetic ingredient; not regulated as a drug

Updated: 2025-06

Biotinoyl Tripeptide-1

Cosmetic ingredient; not regulated as a drug

Updated: 2025-06

Oligopeptide-1 / EGF

Cosmetic ingredient; not regulated as a drug

Updated: 2025-06

Sh-Polypeptide-1

Cosmetic ingredient; not regulated as a drug

Updated: 2025-06

Angiotensin II

FDA-approved drug (Giapreza); not a compounded product

Updated: 2025-06

Nesiritide

FDA-approved drug (Natrecor); not a compounded product

Updated: 2025-06

Octreotide

FDA-approved drug (Sandostatin); not a compounded product

Updated: 2025-06

Lanreotide

FDA-approved drug (Somatuline Depot); not a compounded product

Updated: 2025-06

Pasireotide

FDA-approved drug (Signifor); not a compounded product

Updated: 2025-06

Glucagon

FDA-approved drug (GlucaGen, Baqsimi); not a compounded product

Updated: 2025-06

Teduglutide

FDA-approved drug (Gattex); not a compounded product

Updated: 2025-06

Plecanatide

FDA-approved drug (Trulance); not a compounded product

Updated: 2025-06

Linaclotide

FDA-approved drug (Linzess); not a compounded product

Updated: 2025-06

Abaloparatide

FDA-approved drug (Tymlos); not a compounded product

Updated: 2025-06

Teriparatide

FDA-approved drug (Forteo); not a compounded product

Updated: 2025-06

Calcitonin Salmon

FDA-approved drug (Miacalcin, Fortical); not a compounded product

Updated: 2025-06

PTH (Parathyroid Hormone)

FDA-approved drug (Natpara); available only through REMS

Updated: 2025-06

Afamelanotide

FDA-approved drug (Scenesse); not a compounded product

Updated: 2025-06

Bremelanotide

FDA-approved drug (Vyleesi); not a compounded product

Updated: 2025-06

Difelikefalin

FDA-approved drug (Korsuva); not a compounded product

Updated: 2025-06

Ziconotide

FDA-approved drug (Prialt); not a compounded product

Updated: 2025-06

Romiplostim

FDA-approved biologic (Nplate); not a compounded product

Updated: 2025-06

Enfuvirtide

FDA-approved drug (Fuzeon); not a compounded product

Updated: 2025-06

Icatibant

FDA-approved drug (Firazyr); not a compounded product

Updated: 2025-06

Eptifibatide

FDA-approved drug (Integrilin); not a compounded product

Updated: 2025-06

Bivalirudin

FDA-approved drug (Angiomax); not a compounded product

Updated: 2025-06

Desirudin

FDA-approved drug (Iprivask); not a compounded product

Updated: 2025-06

HGH 191AA

Identical to FDA-approved recombinant growth hormone; compounding not permitted

Updated: 2025-06

AHK (Ala-His-Lys)

Cosmetic/research peptide; not regulated as a drug

Updated: 2025-06

AHK-Cu (Copper AHK)

Cosmetic ingredient; not regulated as a drug

Updated: 2025-06

Decapeptide-12

Cosmetic ingredient; not regulated as a drug

Updated: 2025-06

Melanostatin-DM (Nonapeptide-2)

Cosmetic ingredient; not regulated as a drug

Updated: 2025-06

Nonapeptide-1

Cosmetic ingredient; not regulated as a drug

Updated: 2025-06

Pentapeptide-18 (Leuphasyl)

Cosmetic ingredient; not regulated as a drug

Updated: 2025-06

Rigin (Palmitoyl Tetrapeptide-7)

Cosmetic ingredient; not regulated as a drug

Updated: 2025-06

SYN-AKE

Cosmetic ingredient; not regulated as a drug

Updated: 2025-06

SYN-COLL (Palmitoyl Tripeptide-5)

Cosmetic ingredient; not regulated as a drug

Updated: 2025-06

TRH (Thyrotropin-Releasing Hormone)

FDA-approved diagnostic agent; not a compounded product

Updated: 2025-06

Vialox (Pentapeptide-3)

Cosmetic ingredient; not regulated as a drug

Updated: 2025-06

Pal-GHK (Palmitoyl Tripeptide-1)

Cosmetic ingredient; not regulated as a drug

Updated: 2025-06

Dermorphin

Eloralintide

Enclomiphene

Follistatin

FOXO4-DRI

GHK

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Kisspeptin-10

Pal-AHK

Palmitoyl Dipeptide-6

PGPIPN

Somatropin (rHGH)

DS-5

BPC-157 + TB-500

CAGRILINTIDE + SEMAGLUTIDE

Acetyl Tetrapeptide-3

Cosmetic ingredient, not compounded as a drug.

Cholecystokinin (CCK)

Sincalide is an approved diagnostic drug. Not compounded for weight loss.

Peptide YY (PYY)

Endogenous hormone. Not on FDA compounding list.

CGRP

Endogenous peptide. Anti-CGRP drugs are manufactured pharmaceuticals, not compounded.

9-Me-BC

Not a peptide. Research chemical.

Anamorelin

Peptidomimetic small molecule, not a traditional peptide. Approved drug in Japan.

Amycretin

Investigational compound. Not available for compounding.

Cortexin

Animal-derived extract, not a synthetic peptide. Not applicable for 503A compounding.

Ghrelin

GLP-1

Demoxytocin

HMG

Human Relaxin-2

Prostatilen

Retinalamin

CJC-1295 with DAC

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BAM-15

Myostatin Propeptide

Trevogrumab

Disclaimer: Regulatory data is compiled from publicly available sources and may not reflect the most recent changes. This page is for educational and research purposes only. Consult official regulatory body websites for authoritative information. All Volta Peptides products are for in vitro research use only.

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